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GB 1903.25-2016 English PDF

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GB 1903.25-2016: National Food Safety Standard -- Food Nutritive Fortifier -- D-Biotin
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB 1903.25-2016	English	119	Add to Cart	3 days [Need to translate]	National Food Safety Standard -- Food Nutritive Fortifier -- D-Biotin	Valid	GB 1903.25-2016

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Basic data

Standard ID	GB 1903.25-2016 (GB1903.25-2016)
Description (Translated English)	National Food Safety Standard -- Food Nutritive Fortifier -- D-Biotin
Sector / Industry	National Standard
Classification of Chinese Standard	X40
Word Count Estimation	6,639
Date of Issue	2016-12-23
Date of Implementation	2017-06-23
Regulation (derived from)	National Health and Family Planning Commission Notice No.17 of 2016
Issuing agency(ies)	National Health and Family Planning Commission of the People's Republic of China, State Food and Drug Administration

GB 1903.25-2016: National Food Safety Standard -- Food Nutritive Fortifier -- D-Biotin

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Food safety national standard food nutrition enhancer D - biotin) National Standards of People's Republic of China National Food Safety Standard Fortified Food Biotin D- Published 2016-12-23 2017-06-23 implementation National Health and Family Planning Commission People's Republic of China China Food and Drug Administration issued National Food Safety Standard Fortified Food Biotin D-

1 Scope

This standard applies to bromide, benzene acid, sodium salt as starting material, prepared by chemical synthesis food fortifier D- biotin. Formula 2, Structure and molecular weight Formula 2.1 C10H16N2O3S 2.2 Structure 2.3 Molecular Weight 244.31 (according to 2007 international relative atomic mass)

3 Technical requirements

3.1 Sensory requirements Sensory requirements shall comply with the requirements in Table 1. Table 1 Sensory requirements Project requires test methods Color white or nearly white State crystalline powder or crystal Proper amount of sample is placed in a clean, dry glass beaker colorless , Under natural light, the color observed and the state 3.2 Physical and Chemical Indicators Physical and chemical indicators should be consistent with the provisions of Table 2. Table 2. Physical and chemical indicators Item Index Test Method D- biotin content (dry basis), w /% 98.0 ~ 100.5 Appendix A A.3 Clarity Test by Appendix A A.4 Specific rotation αm (20 ℃, D)/[(°) · m2 · kg-1] 89 ~ 93 GB/T 613a Drying loss, w /% ≤ 1.0 GB 5009.3 direct drying Residue on ignition, w /% ≤ 0.10 GB/T 9741 Lead (Pb)/(mg/kg) ≤ 2.0 GB 5009.75 or GB 5009.12 Arsenic (As)/(mg/kg) ≤ 1.0 GB 5009.76 a solvent 0.1mol/L sodium hydroxide solution, wherein the concentration of the effective component is 2%.

Appendix A

Testing method A.1 General Provisions Unless otherwise specified in this standard, it should be of analytical grade purity of the reagents, the titration standard solution, the determination of impurities with a standard solution, the formulation And products shall GB/T 601, GB/T 602, a predetermined preparation GB/T 603, the test water shall meet the GB/T 6682 in three water gauge set. The test does not indicate when the solution which is formulated with a solvent, refer to the aqueous solution. A.2 Identification Test A.2.1 infrared absorption spectrum test Smear using potassium bromide, infrared absorption spectrum, the infrared spectrum to be measured and the control pattern in accordance with D- biotin GB/T 6040 Consistent (control profile see Appendix B). A.2.2 bromine water fade test Saturated aqueous formulation samples was added dropwise to the orange bromine, bromine water fade. A.3 D- biotin in assay (dry basis) of A.3.1 Reagents and materials A.3.1.1 D- Biotin standard. Purity 99% or more. A.3.1.2 Acetonitrile. chromatographically pure. A.3.1.3 buffer solution. Weigh sodium perchlorate monohydrate 1g, was placed 500mL of water was dissolved, was added 1mL phosphoric acid, dilute to 1000mL. A.3.1.4 diluent. water acetonitrile = 14. A.3.2 Instruments and Equipment HPLC. with UV detector (detection wavelength of 200nm). A.3.3 Reference chromatographic conditions A.3.3.1 Column. 15cm × 4.6mm (inside diameter), the filler particle size 3μm, ODS column, or other equivalent column. A.3.3.2 mobile phase. acetonitrile buffer solution 91.5 = 8.5. A.3.3.3 flow rate. 1.2mL/min. A.3.3.4 injection volume. 50μL. NOTE. The system suitability tailing factor is not more than 1.5, and the standard solution is injected twice repeated, resulting in response to the relative deviation of the average area of less than 2.0%. A.3.4 Analysis step Preparation of standard solution A.3.4.1 Take appropriate standard D- biotin was dissolved in diluents, configured to 0.1mg/mL standard solution, if necessary, sonication completely Dissolved. A.3.4.2 Preparation of test solution Take appropriate sample time D- biotin (via 105 ℃, 4h drying treatment) was dissolved in diluents, configured to sample solution 0.1mg/mL, the necessary Sonication was completely dissolved. A.3.4.3 Determination Under reference chromatographic conditions, the standard solutions were measured and the sample solution, the peak area of the recording, according to formula (A.1) the sample is calculated The content of D- biotin. A.3.5 calculation results D- biotin content (dry basis) the mass fraction w1, calculated according to formula (A.1). w1 = rU rS × cS cU × 100% (A.1) Where. --- rU sample liquid chromatographic analysis of the peak area obtained; Chromatography of rS --- standard solution obtained peak area; cS --- standard solution D- biotin concentration, in milligrams per milliliter (mg/mL); Concentration of the sample solution cU --- D- biotin, in milligrams per milliliter (mg/mL). The test result to the arithmetic mean of replicates results. A.4 Determination of clarity 1.0g sample was taken in 0.5mol/L sodium hydroxide solution, to dissolve the volume to 10.0 mL, solution should be colorless and transparent at this time.

Appendix B

Standard IR spectra of the biotin-D- Standard IR spectra of D- biotin Figure B.1. Note. The quote from "Japanese Pharmacopoeia (JP16)" --- InfraredReferenceSpectra 2011 Nian 4 Yue is effective 1 May. FIG B.1 D- standard infrared spectra of biotin

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